Definition

A study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product or measuring the effectiveness of risk management measures (Decree-Law No. 128/2013 of September 5).

A post-authorisation safety study (PASS) can be performed by amarketing authorizationholder(MAH)voluntarily orby impositionof the competent authority.

INFARMED,I.P. taking into account the European Commission'sguidelines,may force theMAHto conduct aPASSstudyin the following cases: